https://clinicaltrials.gov/ct2/results?cond=&...&dist=


Moderate/severe:

Primary Outcome Measures :
Cumulative incidence of death or respiratory failure until day 28 [ Time Frame: 28 days ]
Rates of participants who attain categories 6, 7, or 8 on the eight-category ordinal scale within 28 days

Not hospitalized, no limitations on activities
Not hospitalized, limitation on activities and/or requiring home oxygen
Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care
Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise)
Hospitalized, requiring supplemental oxygen
Hospitalized, on non-invasive ventilation or high flow oxygen devices
Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO)
Death


Secondary Outcome Measures :
Time to clinical recovery [ Time Frame: 28 days ]
Categories 1, 2 and 3 on a 8-point ordinal scale

Death or intubation until day 28 [ Time Frame: 28 days ]
Categories 7 or 8 on the eight-point ordinal scale

Proportion of patients clinically recovered [ Time Frame: Days 14, 28, 42, and 60 ]
Categories 1, 2 and 3 on a 8-point ordinal scale

All-cause mortality [ Time Frame: Days 14, 28, 42, and 60 ]
Proportion of patients discharged alive [ Time Frame: Days 14, 28, 42, and 60 ]
Categories 1 and 2 on a 8-point ordinal scale

Clinical status [ Time Frame: Days 14, 28, 42, and 60 ]
On a 8 point ordinal scale

Length of hospital stay [ Time Frame: 28 days ]
days

Critical:

Primary Outcome Measures :
Cumulative proportion of clinical recovery [ Time Frame: 28 days ]
Patients will be considered to have recovered if they attain categories 1, 2, or 3 on the eight-category ordinal scale within 28 days, as follows:

Not hospitalized, no limitations on activities
Not hospitalized, limitation on activities and/or requiring home oxygen
Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care
Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise)
Hospitalized, requiring supplemental oxygen
Hospitalized, on non-invasive ventilation or high flow oxygen devices
Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO)
Death


Secondary Outcome Measures :
Proportion of patients clinically recovered [ Time Frame: At days 14, 28, 42, and 60 ]
Ordinal Scale of 1, 2 or 3

All-cause mortality [ Time Frame: At days 14, 28, 42, and 60 ]
All-cause mortality

Proportion of patients discharged alive [ Time Frame: At days 14, 28, 42, and 60 ]
Ordinal Scale 1 or 2

Clinical Status [ Time Frame: Days 14, 28, 42, and 60 ]
Ordinal Scale

Duration of invasive mechanical ventilation or ECMO [ Time Frame: 28 days ]
Days

Length of hospital stay [ Time Frame: 28 days ]
Days

Length of ICU stay [ Time Frame: 28 days ]
Days